Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Eyepoint Pharmaceuticals (EYPT), 503% surge in interest
• Plus Therapeutics (PSTV), 465% surge in interest
• Glycomimetics (GLYC), 436% surge in interest
• BioCryst Pharma (BCRX), 253% surge in interest
• Krystal Biotech (KRYS), 86% surge in interest
• Vertex Pharmaceuticals (VRTX), 66% surge in interest
• Adma Biologics (ADMA), 65% surge in interest
• Gossamer Bio (GOSS), 49% surge in interest
• BioNTech (BNTX), 17% surge in interest

Pipeline and key clinical candidates for these companies:

EyePoint Pharmaceuticals is committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The company’s pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been “safely administered to thousands of patients’ eyes” across four U.S. FDA approved products, including Yutiq for the treatment of posterior segment uveitis, EyePoint says.

Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma and leptomeningeal metastases.

GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including Acute Myeloid Leukemia, and for inflammatory diseases. The company’s specialized chemistry platform is being deployed to discover small molecule drugs–known as glycomimetics–that alter carbohydrate-mediated recognition in diverse disease states.

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily Orladeyo is approved in the United States and many global markets. BioCryst has active programs to develop oral medicines for multiple targets across the complement system, including BCX10013, an oral Factor D inhibitor in clinical development. Rapivab is approved in the U.S. and multiple global markets, with post-marketing commitments ongoing.

Krystal Biotech is a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. The company’s pipeline is based on its proprietary redosable HSV vector. In May, Vyjuvek was approved by the FDA for the treatment of dystrophic epidermolysis bullosa. Vyjuvek is a non-invasive, topical, redosable gene therapy designed to treat DEB at the molecular level.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes and alpha-1 antitrypsin deficiency.

Adma Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Adma currently manufactures and markets three United States Food and Drug Administration-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM for the treatment of primary humoral immunodeficiency; ASCENIV for the treatment of PI; and NABI-HB to provide enhanced immunity against the hepatitis B virus. Through its Adma BioCenters subsidiary, Adma also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products.

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

BioNTech is “pioneering novel therapies for cancer and other serious diseases.” BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab (GMAB), Sanofi (SNY), Genentech, a member of the Roche Group (RHHBY), Regeneron (REGN), Genevant, Fosun Pharma, and Pfizer (PFE).

Recent news on these stocks:

May 8

EyePoint reported Q1 EPS of (55c) against a consensus of (42c), reported Q1 revenue of $11.684M against a consensus of $9.99M. “We have continued advancing our pipeline through significant milestones including the announcement of topline data from our Phase 2 PAVIA clinical trial of DURAVYU in non-proliferative diabetic retinopathy,” said Jay Duker, M.D., CEO of EyePoint Pharmaceuticals. “Although the PAVIA trial did not meet the pre-specified primary endpoint, we were encouraged that DURAVYU demonstrated a biologic effect in patients with NPDR and continues to show a favorable safety and tolerability profile. As such, we plan to assess the full twelve-month study results once they are available to evaluate the path forward for DURAVYU as a potential treatment for NPDR. Looking ahead, we remain on track to initiate the first pivotal Phase 3 LUGANO non-inferiority clinical trial of DURAVYU in wet AMD in the second half of 2024 and for topline data for the Phase 2 VERONA trial in diabetic macular edema in the first quarter of 2025.”

May 7

Vertex Pharmaceuticals reported Q1 EPS of $4.21 against a consensus of $4.06, reported Q1 revenue of $2.69B against a consensus of $2.58B. “Vertex delivered a strong start to 2024 with 13% product revenue growth and outstanding execution across the business. This quarter, we continued to expand our leadership in CF including completion of the regulatory submissions for the vanzacaftor triple, advanced the global launch of CASGEVY, and initiated the rolling submission for suzetrigine in moderate-to-severe acute pain, while progressing our broad and deep pipeline of potentially transformative medicines,” said Reshma Kewalramani, M.D., CEO of Vertex. “We also recently announced the acquisition of Alpine Immune Sciences, a compelling strategic fit. We look forward to welcoming the Alpine team and together accelerating the development of povetacicept, a potential best-in-class treatment for IgAN, and fully exploring povetacicept’s pipeline-in-a-product potential.”

Gossamer Bio reported Q1 EPS of (19c) against a consensus of (19c). Cash, cash equivalents and marketable securities as of March 31, 2024, were $244.4M. Pro forma for the $160M reimbursement payment from Chiesi and the MidCap debt repayment, cash, cash equivalents and marketable securities were $396M as of March 31, 2024. The company expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures into the first half of 2027. “Our team at Gossamer continues to execute on our mission to enhance the lives of patients with pulmonary hypertension, underscored by the transformative development and co-commercialization collaboration with Chiesi that we just announced,” said Faheem Hasnain, CEO of Gossamer Bio. “This transaction immediately adds $160M in cash to our balance sheet and positions us to accelerate seralutinib into a registrational Phase 3 for the treatment of PH-ILD in the middle of next year. The future of Gossamer and seralutinib is exceptionally bright, and we are excited to see what it holds.”

May 6

Plus Therapeutics has entered into a securities purchase agreement with new institutional investors and company insiders to raise up to approximately $18M in gross proceeds, including initial upfront funding of approximately $6.5M, and up to an additional approximately $11.5M upon cash exercise of accompanying warrants at the election of the investors. The financing includes participation from AIGH Capital Management with additional participation from new healthcare-focused institutional investors as well as certain company insiders. Pursuant to terms of the securities purchase agreement, the company will issue up to an aggregate of 3.24M shares of its common stock and accompanying warrants to purchase up to an aggregate of 6.48M shares of its common stock at a combined purchase price of $2.022 per share and accompanying warrants.

GlycoMimetics announced topline results from its Phase 3 global pivotal study of uproleselan in 388 patients with R/R AML. In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone. Patients treated with uproleselan had a median overall survival of 13 months, compared to 12.3 months in the placebo arm. Adverse events were consistent with known side effect profiles of chemotherapy used in the study. The randomized, double-blind, placebo-controlled Phase 3 clinical study evaluated uproleselan in combination with MEC or FAI in patients with R/R AML. The primary endpoint of the study was overall survival without censoring for transplant. Secondary endpoints included incidence of severe oral mucositis, complete remission rate and remission rate. A total of 388 patients across 70 sites in nine countries were randomized 1:1 between treatment and placebo arms.

BioCryst reported Q1 EPS of (17c) against a consensus of (21c), and reported Q1 revenue of $92.8M against a consensus of $85.6M. “We are off to a fantastic start to the year with outstanding ORLADEYO revenue growth and our prioritized pipeline programs advancing on schedule. We are focused on continuing this momentum as we see strong patient demand for ORLADEYO and more pipeline programs advancing into the clinic, starting later this year,” said Jon Stonehouse, CEO of BioCryst.

Krystal Biotech reported Q1 EPS of 3c against a consensus of 15c, and reported Q1 revenue of $45.250M against a consensus of $47.42M. “With strong uptake of VYJUVEK and accelerating enrollment across our growing clinical pipeline, we made great progress this quarter on our mission to deliver transformational genetic medicines to patients with rare and serious diseases,” said Krish Krishnan, Chairman and CEO of Krystal Biotech. “Our U.S. VYJUVEK launch continues to progress well, delivering quarter over quarter revenue growth, and is underpinned by robust demand, rapid growth in reimbursement approvals, and high patient compliance. Momentum outside of the U.S. is also accelerating with the successful completion of our clinical study in Japan putting us on a path for our second ex-U.S. regulatory filing before year end. Our focus looking ahead is to continue expanding VYJUVEK access both in the U.S. and abroad, while progressing our deep clinical pipeline through to key data readouts expected to start later this year.”

BioNTech reported Q1 EPS EUR (1.31) vs. EUR 2.05 last year. Reported Q1 revenue EUR 187.6M vs. EUR 1.28B last year. “In the past weeks, we have reported positive preliminary data for both our individualized and off-the-shelf mRNA-based candidates which further underline the potential of our iNeST and FixVac platforms. We look forward to providing more updates this year across our oncology portfolio, including our bispecific antibody and ADC programs,” said Prof. Ugur Sahin, M.D., CEO of BioNTech. “In the remainder of the year, we plan to develop and commercialize a variant-adapted COVID-19 vaccine and accelerate our clinical development activities towards realizing the full potential of our oncology pipeline with a view to becoming a commercial company with marketed medicines for cancer and infectious diseases.”

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About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.