Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Annexon Announces Mixed Phase 2 Data From Huntington Disease Trial
Annexon, Inc. ANNX announced interim data from its Phase 2 clinical trial of ANX005 in patients with Huntington's disease who completed the 24-week treatment period, showing that treatment with ANX005 has been generally well-tolerated, with full target engagement of C1q in both serum and cerebrospinal fluid observed in evaluable patients through the dosing period.
"Although NfL levels remained consistent with natural history data, the lack of NfL reduction makes it harder to triangulate whether improvement in cUHDRS in a subset of patients is "real," Needham analyst Joseph Stringer said in a note.
The stock was slipping 22.80% to $8.50 in premarket trading.
Amneal Strikes to Deal To Buy 2 Approved Spasticity Drugs And A Pipeline Asset From Saol For $83.5M
Amneal Pharmaceuticals, Inc. AMRX and Saol Therapeutics announced a definitive agreement under which Amneal will acquire Saol's Baclofen franchise, including Lioresal and LYVISPAH as well as a pipeline product under development.
The acquisition expands Amneal's commercial institutional and specialty portfolio in neurology while adding commercial infrastructure in advance of its entry into the biosimilar institutional market. The transaction is expected to be accretive to Amneal's adjusted EBITDA and adjusted earnings per share results for 2022.
Together, Amneal expects these two products to generate between $40 and $50 million in combined annual net revenues by 2025. Under the terms of the transaction, Amneal will pay approximately $83.5 million of cash at close, and certain royalties based on annual net sales for certain acquired products
Amneal shares were up 5.32% at $5.15 in premarket trading.
Click here to access Benzinga's FDA Calendar
NRx Announces Regulatory Submission For Zyesami In Critical COVID-19 Patients
NRx Pharmaceuticals NRXP announced that it has submitted an application for emergency use authorization to the US Food and Drug Administration for the use of Zyesami in patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.
The stock was adding 5.94% to $4.99 in premarket trading.
Inspire Medical Preannounces Positive Q4, FY21 Results
Inspire Medical Systems, Inc. INSP announced preliminary fourth-quarter revenues of $78 million to $78.4 million, up about 78%. Full-year revenues are expected at $233 million to $233.4 million, more than double that of the previous year.
Analysts, on average, estimate revenues of $67.14 million for the quarter and $222.15 million for the year.
The stock was up 4.06% at $242.10 in premarket trading.
Related Link: The Week Ahead In Biotech (Jan 2-Jan. 8): Stray Clinical Readouts In Focus In Slow News Week
Moderna Commences Phase 1 Study Of Vaccine Candidate For Epstein-Barr Virus
Moderna, Inc. MRNA announced the first participant has been dosed in the Phase 1 study of mRNA-1189, its Epstein-Barr Virus vaccine candidate.
Pfizer, BioNTech Announces Shingles Vaccine R&D Collaboration
Pfizer Inc. PFE and BioNTech SE BNTX announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles.
The collaboration builds on the companies' success in developing the first approved and most widely used mRNA vaccine to help COVID-19. This is the third collaboration between prevent Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020.
Pfizer shares were up 1.43% to $55.31 and BioNTech was gaining 1.73% to $227.96.
Zynerba Decides Not to Proceed With Zygel Trials In Epileptic Encephalopathies
Zynerba Pharmaceuticals, Inc. ZYNE provided program updates for Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome and developmental and epileptic encephalopathies.
In addition to the continued clinical development of Zygel in FXS, the company plans to focus on the development of Zygel in ASD and 22q. Based on research and strategic prioritization, the decision has been made to not move forward in DEE at this time.
Angion Commences Phase 2 Study Of ANG-3070 In Primary Proteinuric Kidney
Angion Biomedica Corp ANGN provided a corporate update and announced the first patient has been dosed in its Phase 2 trial of ANG-3070, its lead candidate, in patients with primary proteinuric kidney diseases. The company also said it ended 2021 with approximately $88.8 million in cash and cash equivalents and expects these funds to be sufficient for operations well into 2023.
Cellectis Slips Following Update On Pipeline Programs And Cash Runway
Cellectis CLLS said in 2022, it will be focusing on pursuing recruitments into its core ongoing clinical trials BALLI-01, AMELI-01, MELANI-01 and on filing an investigational new drug application for the first dual allogeneic UCART20x22.
The company also said it is on track to start dosing patients with its in-house manufactured investigational medicinal products during 2022. It also noted that its two manufacturing sites in Raleigh, North Carolina and Paris, France are now fully operational. This focus allows it to extend our cash runway into early 2024, it added.
The stock was down 2.17% at $8.10 in premarket trading.
Biodesix Raises $16.3M In Stock Sales To Pay-off Debt, Announces Amendment To Restrictive Term Loan Covenants
Biodesix, Inc. BDSX announced the sale of 3.76 million common shares on Dec. 30 in an at-the-market offering that raised approximately $16.3 million in gross proceeds to fund repayment of its existing term loan.
Additionally, the company said it entered into a second amendment to its $30 million 2021 term loan, which includes modifications to certain restrictive financial covenants to provide additional financial flexibility over the near term to advance its strategic growth objectives.
The stock was up 10.57% at $5.86 in premarket trading.
Oncternal Announces Positive End-of-Phase 2 Meeting With FDA Regarding Its Mantle Cell Lymphoma Candidate
Oncternal Therapeutics, Inc. ONCT announced that following a successful End-of-Phase 2 meeting with the FDA for zilovertamab, its investigational anti-ROR1 monoclonal antibody, the company and the FDA agreed on key elements of the company's potentially pivotal Phase 3 clinical trial of zilovertamab for the treatment of patients with relapsed or refractory mantle cell lymphoma.
The FDA has also reviewed and agreed upon the key design features and operational details of the company's Phase 3 clinical trial protocol and statistical analysis plan, which is being finalized based on the FDA's input.
The stock was up 2.56% at $2.40 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
Mersana Gains On Insider Buying
Mersana Therapeutics, Inc. MRSN disclosed in a filing that Andrew Hack, a director of its board, bought 815,000 shares in the company.
The stock was adding 5.39% to $6.84 in premarket trading.
Innate Pharma Gets $32.5M In Non-Dilutive Financing From French Banks
Innate Pharma SA IPHA said it has obtained a 28.7-million-euro ($32.5 million) in non-dilutive financing in the form of two loans from Société Générale and BNP Paribas.
The two loans have an initial term of one year with a five-year extension option. They are 90% guaranteed by the French state as part of the package of measures put in place by the French government to support companies during the COVID-19 pandemic.
Clinical Readouts/Presentations
Connect Biopharma Holdings Limited CNTB will host a conference call and webcast to review detailed data from its global Phase 2b trial of CBP-201 in adult patients with moderate-to-severe atopic dermatitis, beginning at 8:30 a.m.
Edgewise Therapeutics, Inc. EWTX is scheduled to report topline results from the Phase 1b clinical trial of EDG-5506 in individuals with Becker muscular dystrophy at 9 a.m.
Sutro Biopharma, Inc. STRO is due to provide interim data from the dose-expansion cohort of the Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with advanced ovarian cancer at a company-hosted KOL virtual event. The event and Q&A session will be available by webcast, to be held at 5 p.m. ET.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
