Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
FDA Committee Backs Pfizer, Moderna COVID-19 Vaccines For Toddlers, Youngest Children
The FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of amending the emergency use authorization (EUA) for Moderna Inc's (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE)/BioNTech SE (NASDAQ:BNTX) COVID-19 vaccines for children as young as six months through five years old.
The favorable vote followed a VRBPAC meeting where the committee unanimously voted 22-0 to recommend Moderna's COVID-19 vaccine as a two-dose series for children six years and older.
Valneva Settles COVID-19 Vaccine Agreement With UK Government
Valneva SE (NASDAQ:VALN) reached a settlement agreement with the British government linked to the termination of the supply agreement for its COVID-19 vaccine candidate VLA2001.
Valneva said in September that it had received a termination notice from the British government of its COVID-19 vaccine supply deal.
The settlement agreement resolves certain matters relating to the obligations of the company and the British government following the termination of the supply agreement, Valneva said.
Valneva's statement said it also resolved matters concerning the separate agreement relating to clinical trials of VLA2001 in the U.K., which remains in place.
Moderna Plans COVID-19 Vaccine Trial For Infants
Moderna Inc (NASDAQ:MRNA) is reportedly planning to evaluate its COVID-19 vaccine in infants aged three months to six months.
According to the Wall Street Journal report, the company is in the final stages of planning the study, to be named BabyCove.
It is expected to begin enrolling approximately 700 babies in September.
Biogen Terminates 2018 Asset Purchase Agreement With Karyopharm Therapeutics
Biogen Inc. (NASDAQ:BIIB) has informed Karyopharm Therapeutics Inc (NASDAQ:KPTI) that it has opted to terminate the companies' Asset Purchase Agreement announced in January 2018, as amended.
Per the agreement, Karyopharm sold rights of its oral Selective Inhibitor of Nuclear Export compound KPT-350 and certain related assets to Biogen.
Aquestive Therapeutics Shares Favorable Data From Epinephrine Trial For Allergic Reactions
Aquestive Therapeutics Inc (NASDAQ:AQST) announced topline results from the first three arms of Part 3 of the EPIPHAST study for its AQST-109 epinephrine oral film for allergic reactions, including anaphylaxis.
In the first three arms of Part 3, AQST-109 12 mg continued to show rapid absorption with favorable pharmacokinetics.
The median time to maximum concentration was 12 minutes for AQST-109 compared to 50 minutes for the epinephrine 0.3mg intramuscular (IM) injection, the fastest median time in studies to date.
Roche-AC Immune's Crenezumab Fails To Show Benefit In Subset Of Alzheimer's Patients
Roche Holdings AG (OTC:RHHBY) said its Alzheimer's medicine crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation that causes early onset disease.
Crenezumab did not show a statistically significant clinical benefit in its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function.
Crenezumab was discovered by AC Immune SA (NASDAQ:ACIU) and designed to neutralize a pathological species of the beta-amyloid protein called oligomers.
Shares are down 31% at $1.98 during the premarket session.
Checkpoint Shares Jump As Therapy Shows Almost 55% Response Rate In Skin Cancer
Checkpoint Therapeutics Inc (NASDAQ:CKPT) announced positive interim efficacy results from its registration-enabling trial of cosibelimab in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.
As of the March 2022 data cutoff, the objective response rate (ORR) in 31 patients was 54.8%, substantially exceeding a clinically meaningful lower bound of 25%.
Shares are up 12% at $1.21 during the premarket session.
Exelixis, BioInvent Establish Immuno-Oncology Pact
Exelixis Inc (NASDAQ:EXEL) and BioInvent International AB have entered into an option and license agreement focused on identifying and developing novel antibodies for immuno-oncology therapeutics.
Exelixis will pay BioInvent an upfront fee of $25 million in exchange for rights to select three targets identified using BioInvent's proprietary F.I.R.S.T platform and n-CoDeR library.
Acorda Shares Surge on Parkinson's Treatment Launch In Germany
Acorda Therapeutics Inc (NASDAQ:ACOR) announced that Esteve Pharmaceuticals GmbH launched INBRIJA 33 mg (levodopa inhalation powder, hard capsules) in Germany.
INBRIJA is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease treated with a levodopa/dopa-decarboxylase inhibitor.
Acorda expects to start receiving revenue from the product supply during the second quarter of 2022.
Shares are up 46% at 59 cents during the premarket session.
Insider Trading
Repare Therapeutics Inc (NASDAQ:RPTX): Mark Lampert, owning over 10% stock, reported purchasing 149,161 shares at $12.73/share in Form 4 filing.
Offerings
Arcellx Inc (NASDAQ:ACLX) priced an upsized underwritten follow-on offering of 7 million at $16 per share from the original 4 million shares.
The gross proceeds are expected to be $112 million.
On The Radar
PDUFA Dates
Rhythm Pharmaceuticals Inc (NASDAQ:RYTM): Expanded use for (setmelanotide) for obesity in patients with Bardet-Biedl syndrome.
