The Daily Biotech Pulse: Biogen Slumps As CMS Announces Restrictive Coverage For Aduhelm, Aclaris CMO Departs, Immuron Spikes On US Military Award

By Shanthi Rexaline

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

Stocks In Focus

Biogen Shares Slip On Restricted Coverage For Its Alzheimer's Drug

Biogen, Inc. (NASDAQ:BIIB) shares were reacting to a verdict from the Centers for Medicare and Medicaid Services regarding limited coverage for its Alzheimer's disease drug Aduhelm.

The CMS statement suggested that it would cover the cost of treatment only if patients are enrolled in clinical studies.

"Biogen believes that the proposed coverage with evidence development (CED) decision for anti-amyloid therapies denies nearly all Medicare beneficiaries from accessing ADUHELM," the company said in a statement.

It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA, it added.

The stock was slipping 9.22% to $219.25 in premarket trading.

Aclaris Announces Departure Of Chief Medical Officer

Providing a R&D update, Aclaris Therapeutics, Inc. (NASDAQ:ACRS) said David Gordon, its chief medical officer left the company, effective Jan. 7. The company also announced update on its two Phase 2 programs that evaluate zunsemetinib in subjects with moderate to severe rheumatoid arthritis and in subjects with moderate to severe hidradenitis suppurative.

The stock was slipping 2.80% at $12.50 in premarket trading.

Click here to access Benzinga's FDA Calendar

Pfizer Announces Positive Phase 3 Data For Prevnar 20 Co-Administered With COVID-19 Vaccine

Pfizer Inc. (NYSE:PFE) announced positive top-line results from a Phase 3 study describing the safety and immunogenicity of Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the U.S., 65 years of age or older when administered at the same time as the Pfizer-BioNTech SE (NASDAQ:BNTX) COVID-19 Vaccine or when each vaccine was given with placebo.

atai Gets FDA Clearance For Conducting Drug-Drug Interaction Study Of PCN-101

atai Life Sciences N.V. (NASDAQ:ATAI) announced the FDA has given Investigational new drug clearance to conduct a clinical drug-drug interaction study of PCN-101. atai plans to initiate the study early this year through its platform company Perception Neuroscience.

The stock was gaining 6.08% to $7.15 in premarket trading

Ocugen Says Booster Dose Of Partnered COVID-19 Vaccine Found Effective Against Omicron And Delta Variants

Ocugen, Inc. (NASDAQ:OCGN) and its partner, Bharat Biotech announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of candidate vaccine Covaxin six months after getting a primary two-dose series neutralized the SARS-CoV-2 omicron and delta variants.

Ocugen shares were up 4.33% at $4.34 in premarket trading.

Immuron Announces $4.45M Funding From U.S. Military For Travelan

Immuron Limited (NASDAQ:IMRN) said it was awarded $3.43 million funding by the U.S. Department of Defense for Travelan. The company also noted that the U.S Naval Medical Research Center received $1.02 million funding to support the Travelan clinical development effort, taking the total award to $4.45 million to examine a dosing regimen for Travelan more suited for use by the military.

The shares were jumping 71.76% to $4.52 in premarket trading.

BeyondSpring Announces Organizational Restructuring That Includes Workforce Reduction

BeyondSpring Inc. (NASDAQ:BYSI) announced an organizational streamlining initiative focused on prioritizing the company's highest value business activities, extending its cash runway and preserving long-term sustainability.

As part of the reorganization, BeyondSpring said it is reducing its U.S. workforce by 35%, including reassignment of certain personnel to subsidiaries, which is expected to result in cost savings that will extend the cash runway. The reorganization follows BeyondSpring's receipt of a complete response letter from the U.S. Food and Drug Administration for its plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in late November.

Glaukos Announces Positive Data For Phase 2b Study Of Interocular Pressure Treatment And Commencement Of Two Phase 2 Studies

Glaukos Corporation (NYSE:GKOS) announced that its iDose TR sustained-release travoprost implant continued to provide sustained substantial reductions in intraocular pressure in a 36-month analysis of the 36-month Phase 2b clinical trial conducted under a U.S. investigational new drug protocol.

Separately, the company announced commencement the Phase 2 clinical trial of GLK-301 for the treatment of signs and symptoms of dry eye disease and the Phase 2 clinical trial of GLK-302 for the treatment of presbyopia.

NeuroPace Preannounces Above-Consensus Q4 Revenues

NeuroPace, Inc. (NASDAQ:NPCE) announced preliminary fourth quarter revenue of about $11 million, compared to $10.8 million in the year-ago quarter. The consensus forecast calls for revenues of $10.08 million.

IMV Announces Commencement Of Phase 2b Study Of Maveropepimut-S-Keytruda Combo In Blood Cancer

IMV Inc. (NASDAQ:IMV) announced a first patient dosed in the Phase 2b clinical trial that will further evaluate the clinical benefit of its lead compound, maveropepimut-S in combination with Merck & Company, Inc.'s (NYSE:MRK) Keytruda in patients with relapsed/refractory diffuse large B cell lymphoma. The contribution of low dose cyclophosphamide as an immune modulator will also be evaluated in this trial.

IMV shares were rising 4.76% to $1.32 in premarket trading.

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

On The Radar

IPOs

Bridgewater, New Jersey-based Hillstream Biopharma, Inc. (NASDAQ:HILS) priced its upsized initial public offering of 3.75 million shares at $4, below the estimated price range of $5-$6. The shares will begin trading on the Nasdaq under the ticker symbol HILS. Net proceeds from the offering is expected to be $15 million.

Hillstream is a pre-clinical biotechnology company developing therapeutic candidates targeting ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death for treatment resistant cancers.


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