The Daily Biotech Pulse: Double Dose Of Positive Tidings For Merck, Alkermes Slips On Partial Termination Of J&J Licensing Deal, Amgen Migraine Drug Data

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

Stocks In Focus

Merck Gets Antitrust Nod For Acceleron Deal In Germany, Austria, Announces Procurement Of 1.4M Additional Doses Of COVID-19 Pill By U.S.

Merck & Co., Inc. MRK said its pending acquisition of Acceleron Pharma, Inc. XLRN has been cleared by the competition authorities in Germany and Austria.

The cash tender offer Merck has commenced to purchase all outstanding shares of common stock of Acceleron, for $180 per share in cash will expire at 5 p.m. on Nov. 18.

The acquisition is expected to close in the fourth quarter.

Separately, Merck and Ridgeback Biotherapeutics announced the U.S. government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted emergency use authorization or approval by the U.S. Food and Drug Administration, for approximately $1 billion.

With these exercised options, the U.S. has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022. The U.S. government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract.

Merck shares were up 1.29% at $83.75 in premarket trading.

Alkermes Receives Partial Termination Notices For Licensing Agreement With Janssen Over Technology Uses In Latter's Antipsychotic Drugs

Alkermes plc ALKS announced that it received notices of partial termination of two license agreements with Johnson & Johnson JNJ's Janssen unit. The terminations impact know-how royalties related to sales of long-acting paliperidone products, such as Invega Sustenna and Invega Trinza in the U.S.

Even as Janssen maintained that it does not utilize Alkermes' "NanoCrystal" technology licensed under the agreements, Alkermes said it strongly disagrees with Janssen's position. The latter also said it will explore all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

Alkermes shares were receding 7.94% to $27 in premarket trading.

Related Link: The Week Ahead In Biotech (Nov. 7-Nov. 13): Earnings Taper Off, Multiple Conference Presentations, IPOs And More

Amgen Migraine Treatment Found Superior To Standard-Of-Care In Phase 4 Study

Amgen, Inc. AMGN announced new data from the a head-to-head Phase 4 study of Aimovig, a CGRP inhibitor, against topiramate for adult patients with episodic and chronic migraine. Topiramate is one of the most commonly prescribed medications in migraine prevention.

The study conducted by Novartis AG NVS showed that patients in the Aimovig treatment arm experienced a significantly lower discontinuation rate due to adverse events and superior efficacy, with a greater proportion of patients achieving at least a 50% reduction from baseline in their monthly migraine days compared with topiramate.

Tonix Presents Positive Results For Late-Stage Study Of TNX-102 In Fibromyalgia

Tonix Pharmaceuticals Holding Corp. TNXP announced an oral presentation of positive results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia.

TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ≥30% pain responder analysis, there was a higher rate of responders to TNX-102 SL than to placebo. TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue and fibromyalgia-specific functional recovery.

The stock was up 4.15% at 58 cents in premarket trading.

Management Changes

Histogen Inc. HSTO announced that that Steven Mento, a current member of its board, has been appointed executive chairman and interim president and chief executive officer effective immediately. This follows Richard Pascoe, the incumbent, stepping down effective immediately to pursue different opportunities.

The stock was slipping 2.59% to 71 cents in premarket trading.

Progenity, Inc. PROG, announced the appointment of Adi Mohanty as CEO of the company, effective Nov. 8. Mohanty also joins the Progenity's board. In early September, the company announced Harry Stylli had resigned as the CEO effective immediately.

In premarket trading, the stock was down 2.26% at $3.46.

Earnings

Mirati Therapeutics, Inc. MRTX said revenues, comprising solely of license and collaboration revenues, rose to $71.93 million in the third quarter of 2021, up from $11.42 million in the year-ago period. The loss per share narrowed from $1.96 to $1.55.

The stock was up 8.8% at $173.98 in premarket trading.

Invitae Corporation NVTA reported revenues of $114.4 million in the third quarter, a more than 66% increase compared to $68.7 million in the same period in 2020. The non-GAAP loss per share was 81 cents. The company lowered its 2021 annual revenue guidance from a range of $475 million to $500 million to a range of $450 million-$475 million.

The stock was sliding 11.88% to $23.15 in premarket trading.

Offerings

Chinook Therapeutics, Inc. KDNY said it intends to offer and sell 6 million shares of its common stock in an underwritten public offering. All of the shares will be offered and sold by Chinook.

In premarket trading, the stock was slipping 1.06% to $14.04.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts/Presentations

14th Clinical Trial On Alzheimer's Disease Meeting Presentations

Alector, Inc. ALEC: Phase 1 data for AL003 in Alzheimer's disease, Update on the Phase 2 study of AL001 in frontotemporal dementia patients carrying a granulin Mutation

Annovis Bio, Inc. ANVS: Positive clinical outcomes of posiphen in two phase 2a studies - Alzheimer's disease and Parkinson's disease

AC Immune SA ACIU: topline results from Phase 2 study of Semorinemab in Alzheimer's disease, additional Phase 2 data for ACI-24 in Alzheimer's disease

Biogen Inc. BIIB: top-line results from TANGO, a Phase 2 study of gosuranemab in participants with mild cognitive impairment due to Alzheimer's disease

Cortexyme, Inc. CRTX: topline results from the Phase 2/3 study of Atuzaginstat in mild to moderate Alzheimer's disease

Earnings

• Eagle Pharmaceuticals, Inc. EGRX (before the market open)
• Dicerna Pharmaceuticals, Inc. DRNA (before the market open)
• Mersana Therapeutics, Inc. MRSN (before the market open)
• Evaxion Biotech A/S EVAX (before the market open)
• Applied Genetic Technologies Corporation AGTC (before the market open)
• Amicus Therapeutics, Inc. FOLD (before the market open)
• IVERIC bio, Inc. ISEE (before the market open)
• Selecta Biosciences, Inc. SELB (before the market open)
• Ocugen, Inc. OCGN (before the market open)
• Concert Pharmaceuticals, Inc. CNCE (before the market open)
• Vericel Corporation VCEL (before the market open)
• Intra-Cellular Therapies, Inc. TCI (before the market open)
• Haemonetics Corporation HAE (before the market open)
• Epizyme, Inc. EPZM (before the market open)
• BioNTech SE BNTX (before the market open)
• Biohaven Pharmaceutical Holding Company Ltd. BHVN (before the market open)
• Cardiovascular Systems, Inc. CSII (before the market open)
• ChemoCentryx, Inc. CCXI (after the close)
• FibroGen, Inc. FGEN (after the close)
• Fulgent Genetics, Inc. FLGT (after the close)
• Inovio Pharmaceuticals, Inc. INO (after the close)
• Jazz Pharmaceuticals plc JAZZ (after the close)
• Ligand Pharmaceuticals Incorporated LGND (after the close)
• Silk Road Medical, Inc SILK (after the close)
• Aethlon Medical, Inc. AEMD (after the close)
• Aptinyx Inc. APTX (after the close)
• Achieve Life Sciences, Inc. ACHV (after the close)
• Agenus Inc. AGEN (after the close)
• Calithera Biosciences, Inc. CALA (after the close)
• Omeros Corporation OMER (after the close)
• Capricor Therapeutics, Inc. CAPR (after the close)
• CorMedix Inc. CRMD (after the close)
• Revance Therapeutics, Inc. RVNC (after the close)
• Turning Point Therapeutics, Inc. TPTX (after the close)
• Neovasc Inc. NVCN (after the close)
• Veracyte, Inc. VCYT (after the close)
• Recro Pharma, Inc. REPH (after the close)
• NuVasive, Inc. NUVA (after the close)
• Inari Medical, Inc. NARI (after the close)
• Nabriva Therapeutics plc NBRV (after the close)
• OncoCyte Corporation OCX (after the close)
• Catalyst Pharmaceuticals, Inc. CPRX
• Cumberland Pharmaceuticals Inc. CPIX (after the close)
• MannKind Corporation MNKD (after the close)
• DermTech, Inc. DMTK (after the close)
• Organogenesis Holdings Inc. ORGO (after the close)

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