The Daily Biotech Pulse: Acadia Jumps On Data, vTv Shelves Psoriasis Study, More Setbacks For Merck's HIV Program, Decision Day For Daré

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Acadia Announces Positive Phase 3 Data For Trofinetide In Rett Syndrome

Acadia Pharmaceuticals Inc. ACAD announced positive top-line results from a pivotal Phase 3 study evaluating the efficacy and safety of trofinetide in 187 girls and young women ages 5-20 with Rett syndrome.

The 12-week placebo-controlled study demonstrated a statistically significant improvement over placebo for both co-primary endpoints.

"The positive Lavender study results support a potential treatment for Rett syndrome and represent an important step forward in addressing this rare and serious neurological disease," said Jeffrey L. Neul, a study investigator.

The stock was up 15.98% to $22.50 in premarket trading.

vTv Stalls Psoriasis Study, Reduces Workforce Amid Focus On Lead Diabetes Program

vTv Therapeutics VTVT announced the prioritization of its lead program TTP399 as it gears up for Phase 3 pivotal trials. Due to the strategic shift, Due to its shift in strategic focus, the company said it reduced its workforce by approximately 65% and paused development activities on HPP737, a PDE4 inhibitor for treatment of psoriasis, while it evaluates strategic options.

The stock was gaining 7.96% at $1.22 in premarket trading.

Merck Pauses Enrollment In 2 Late-Stage Studies Of HIV Drug

Merck & Co., Inc. MRK announced a pause in enrollment for the IMPOWER 22 and IMPOWER 24 Phase 3 clinical studies evaluating investigational, once-monthly oral islatravir for pre-exposure prophylaxis in people at high risk of HIV-1 infection.

The pause was done at the recommendation of the external data monitoring committee, and while the company conducts further analysis of these and other ongoing studies. Participants already enrolled in the trials will continue to receive the study medicine.

The company said it is implementing additional monitoring measures for study participants, including increasing the frequency of total lymphocyte and CD4+ T-cell assessments.

In late November, Merck and Gilead Sciences, Inc. GILD announced a temporary pause in the Phase 2 study evaluating the combination regimen of islatravir and lenacapavir in HIV infection.
Merck shares were slipping 1.66% to $72.20 in premarket trading.

Related Link: The Week Ahead In Biotech (Dec. 6-Dec. 11): Daré FDA Decision, Adcom Tryst For Reata, Multiple Conference Presentations And More

Vir-GSK's Antibody Treatment Sotrovimab Retains In Vitro Activity Against Omicron Variant

Vir Biotechnology, Inc. VIR and partner GlaxoSmithKline plc GSK announced an update to preclinical data on bioRxiv, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant.

Vir's management will host a conference call at 8:30 a.m. to discuss new data.

Vir shares were moving up 11.23% to $42.70 in premarket trading.

Ionis, AstraZeneca To Collaborate On Antisense Therapy For Transthyretin Amyloidosis

Ionis Pharmaceuticals, Inc. IONS said it has entered into a strategic collaboration agreement with AstraZeneca plc AZN to develop and commercialize eplontersen, Ionis' investigational antisense medicine for the treatment of transthyretin amyloidosis.

While Ionis will be responsible for the conduct of the Phase 3 studies and manufacture and supply of the investigational compound, both companies will have shared responsibility for medical affairs and commercial activities in the U.S. The U.K. drug giant will have exclusive license for eplontersen outside the U.S. except certain countries in Latin America.

The agreement is expected to become effective by the end of 2021.

Ionis shares were adding 9.05% to $29.99 in premarket trading, while AstraZeneca was slipping 1.12% to $54.79.

Tayshe Presents Positive Preclinical Data For Gene Therapy To Treat Epilepsy

Taysha Gene Therapies, Inc. TSHA announced a late-breaking abstract and poster presentation on positive preclinical data for TSHA-105, an AAV9-based gene therapy in development for SLC13A5-related epilepsy at the American Epilepsy Society Annual Meeting.

In premarket trading, the stock was up 2.32% to $13.25.

Bellus Health Rises On Disclosure Of Fund Stake

BELLUS Health Inc. BLU gained ground after a SEC filing revealed that Perceptive Advisory owns 4.74 million shares, or about a 6.1% stake in the company.

In premarket trading, the stock was adding 15% to $6.21.

Aptinyx Gains On Insider Buying

Aptinyx Inc. APTX disclosed in a filing that its CFO and chief business officer Ashish Khanna bought 45,000 shares in the company.

The stock was advancing 7.83% to $2.34 in premarket trading.

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On The Radar


The Food and Drug Administration is scheduled to rule on Daré Bioscience, Inc.'s DARE new drug application for Dare-BV1, an investigational treatment for bacterial vaginosis.

Clinical Readouts

MeiraGTx Holdings plc MGTX is hosting a conference call and webcast to provide at 8 am, on its AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia.

IDEAYA Biosciences, Inc. IDYA has scheduled a conference call at 8:30 am, to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib and crizotinib combination in patients with metastatic uveal melanoma.

2021 San Antonio Breast Cancer Symposium Presentations

Gilead Sciences, Inc. GILD: Phase 3 data from the ASCENT study of Sacituzumab Govitecan in metastatic triple-negative breast cancer, or TNBC

OncoSec Medical Incorporated ONCS: updated Phase 2 data for Tavo from the KEYNOTE-890 clinical trial in combination with Keytruda with or without chemotherapy in patients with inoperable locally advanced or metastatic TNBC

Infinity Pharmaceuticals, Inc. INFI: Updated safety and efficacy data from the Phase 2 study evaluating eganelisib in a novel triple combination with Roche Holding AG's RHHBY Tecentriq and Abraxane in unresectable locally advanced or metastatic TNBC

32nd International Symposium On Amyotrophic Lateral Sclerosis, or ALS/Motor Neurone Disease Presentations

Cytokinetics, Incorporated CYTK: Updated data from the Phase 3 study of Reldesemtiv in ALS patients


Renalytix Plc RNLX

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

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