The Daily Biotech Pulse: Takeda Suspends Studies On Safety Scare, Acer's Sleep Disorder Drug Filing Accepted For Review, Voyager's Licensing Options Deal

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Oct. 5)

• Bicycle Therapeutics plc BCYC
• Biohaven Pharmaceutical Holding Company Ltd. BHVN (announced migraine drug sales of $136 million in the third quarter)
• Cytokinetics, Incorporated CYTK
• Legend Biotech Corporation LEGN
• Opiant Pharmaceuticals, Inc. OPNT
• Xenon Pharmaceuticals Inc. XENE

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 5)

• Abeona Therapeutics Inc. ABEO
• Acutus Medical, Inc. AFIB
• Angion Biomedica Corp. ANGN
• Applied Genetic Technologies Corporation AGTC
• Applied Molecular Transport Inc. AMTI
• Aravive, Inc. ARAV
• Aridis Pharmaceuticals, Inc. ARDS
• Assertio Holdings, Inc. ASRT
• Atai Life Sciences N.V. ATAI
• Athenex, Inc. ATNX
• Athersys, Inc. ATHX
• Avenue Therapeutics, Inc. ATXI
• Axcella Health Inc. AXLA
• BiondVax Pharmaceuticals Ltd. BVXV
• BioSig Technologies, Inc. BSGM
• BioVie Inc. BIVI
• Black Diamond Therapeutics, Inc. BDTX
• Burning Rock Biotech Limited BNR
• Caladrius Biosciences, Inc. CLBS
• Cardiovascular Systems, Inc. CSII
• Centessa Pharmaceuticals Limited CNTA
• Catalyst Pharmaceuticals, Inc. CPRX
• Checkmate Pharmaceuticals, Inc. CMPI
• Chemomab Therapeutics Ltd. CMMB
• Concert Pharmaceuticals, Inc. CNCE
• Cue Health Inc. HLTH (IPOed Sept. 24)
• DICE Therapeutics, Inc. DICE
• DURECT Corporation DRRX
• Eledon Pharmaceuticals, Inc. ELDN
• Ensysce Biosciences, Inc. ENSC
• Esperion Therapeutics, Inc. ESPR
• Exscientia Limited EXAI (IPOed Friday)
• Forte Biosciences, Inc. FBRX
• Galapagos NV GLPG (announced positive data for filgotinib in ulcerative colitis)
• Galecto, Inc. GLTO
• Gamida Cell Ltd. GMDA
• Graphite Bio, Inc. GRPH
• Harpoon Therapeutics, Inc. HARP
• HCW Biologics Inc. HCWB
• Heron Therapeutics, Inc. HRTX
• Histogen Inc. HSTO
• HOOKIPA Pharma Inc. HOOK
• Hoth Therapeutics, Inc. HOTH
• IMARA Inc. IMRA
• Immunic, Inc. IMUX
• Immuron Limited IMRN
• Incyte Corporation INCY
• InMed Pharmaceuticals Inc. INM
• Inozyme Pharma, Inc. INZY
• Jazz Pharmaceuticals plc JAZZ
• Jasper Therapeutics, Inc. JSPR
• Kala Pharmaceuticals, Inc. KALA
• Kaleido Biosciences, Inc. KLDO (announced positive topline data from the non-IND/CTA clinical study of KB295, a microbiome metabolic therapy, in ulcerative colitis)
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kintara Therapeutics, Inc. KTRA
• Kiromic BioPharma, Inc. KRBP
• Lantern Pharma Inc. LTRN
• Liminal BioSciences Inc. LMNL
• Lipocine Inc. LPCN
• Lixte Biotechnology Holdings, Inc. LIXT
• LumiraDx Limited LMDX
• Madrigal Pharmaceuticals, Inc. MDGL
• MediWound Ltd. MDWD
• Mesoblast Limited MESO
• Minerva Neurosciences, Inc. NERV
• Mustang Bio, Inc. MBIO
• NeuroBo Pharmaceuticals, Inc. NRBO
• NovoCure Limited NVCR
• Omeros Corporation OMER
• Orchard Therapeutics plc ORTX
• Oyster Point Pharma, Inc. OYST
• Orphazyme A/S ORPH ( provided regulatory update for arimoclomol)
• Pacira BioSciences, Inc. PCRX
• Panbela Therapeutics, Inc. PBLA
• Pasithea Therapeutics Corp. KTTA
• Passage Bio, Inc. PASG
• Pharming Group N.V. PHAR
• POINT Biopharma Global Inc. PNT
• Poseida Therapeutics, Inc. PSTX
• PTC Therapeutics, Inc. PTCT
• Puma Biotechnology, Inc. PBYI
• RenovoRx, Inc. RNXT
• Roivant Sciences Ltd. ROIV (listed Friday following a SPAC deal)
• Sangamo Therapeutics, Inc. SGMO
• Scopus BioPharma Inc. SCPS
• Spectrum Pharmaceuticals, Inc. SPPI
• Surrozen, Inc. SRZN
• Teligent, Inc. TLGT
• Titan Pharmaceuticals, Inc. TTNP
• Tiziana Life Sciences PLC TLSA
• Trevi Therapeutics, Inc. TRVI
• Tyra Biosciences, Inc. TYRA (IPOed Sept. 15)
• Unity Biotechnology, Inc. UBX (announced 12-week data from the 1 safety study of UBX1325 in patients with advanced vascular eye disease)
• VectivBio Holding AG VECT
• Verona Pharma plc VRNA
• Vertex Pharmaceuticals Incorporated VRTX
• Viveve Medical, Inc. VIVE
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE
• Wave Life Sciences Ltd. WVE
• XBiotech Inc. XBIT

Click here to access Benzinga's FDA Calendar

Stocks In Focus

Takeda Suspends Two Phase 2 Studies of Sleep Disorder Treatment Candidate Due to Safety Scare

Takeda Pharmaceuticals Company Limited TAK said a safety signal has emerged in Phase 2 studies of TAK-994, an investigational oral orexin agonist that is being evaluated for narcolepsy. As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2 studies early. This allows for the timely interpretation of the benefit /risk profile of TAK-994 and to determine next steps for the program.

"We are working to quickly assess the totality of available data to inform the further development of TAK-994," the company said.

The stock was down 4.54% at $15.35 in premarket trading.

Acer's Regulatory Application For Urea Cycle Disorder Drug Accepted For Review

Acer Therapeutics Inc. ACER and its collaboration partner Relief Therapeutics Holding AG RLFTF announced that the U.S. Food and Drug Administration has accepted filing the new drug application for ACER-001 for the treatment of patients with urea cycle disorders. The FDA has assigned a PDUFA target action date of June 5, 2022.

Acer shares were surging up 25.30% to $3.12 in premarket trading.

Voyager Signs License Options Agreement With Pfizer Valued Up to $600M

Voyager announced an agreement through which Pfizer Inc PFE may exercise options to license novel capsids generated from Voyager's RNA-driven TRACER screening technology as part of the latter's efforts to develop, manufacture, and commercialize gene therapies, utilizing two undisclosed transgenes to treat certain neurologic and cardiovascular diseases.

Voyager will receive $30 million upfront and is entitled to receive up to $20 million in exercise fees for two options, exercisable by Pfizer within 12 months of signing. In addition, Voyager will be eligible to earn up to $580 million in total development, regulatory, and commercial milestones associated with licensed products

Voyager is also eligible to receive mid- to high-single-digit tiered royalties based on net sales of Pfizer's products incorporating the licensed capsids.

In premarket trading, Voyager shares were soaring 43.73% to $3.55.

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

Kiromic Announces Abrupt Departure of CFO

Kiromic announced it has appointed company insider Daniel Clark as interim chief financial officer, effective as of Sept. 30. The company also disclosed that its previous CFO Tony Tontat, resigned on Sept. 29, effective immediately.

Surrozen Announces Presentation of Positive Pre-clinical Data For Its Inflammatory Bowel Disease Program

Surrozen announced that data from its inflammatory bowel disease program, including preclinical studies of SZN-1326 showing colonic mucosal healing in an acute injury model were presented during the 2021 United European Gastroenterology Week.

"We believe that SZN-1326 is positioned to transform the treatment paradigm for patients suffering from IBD including Crohn's disease and ulcerative colitis," said Craig Parker, President and CEO of Surrozen.

The stock was up 4.33% at $6.50 in premarket trading.

RedHill Announces California Medicaid Health Coverage For Bacterial Infection Treatment

RedHill Biopharma Ltd. RDHL said Medi-Cal - California's Medicaid Health Care program covering two million patients - has added its Talicia to its contract drug list for H. pylori treatment, with no prior authorization required, effective Oct. 1.

Coverage for Talicia commenced for two million patients in Medi-Cal's California FFS plan, the company added.

The stock was up 3.617% at $4.87 in premarket trading.

On The Radar

Clinical Readouts/Presentations

Denali Therapeutics Inc. DNLI is due to present at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis meeting data from a Phase 2, study, followed by an open-label long-term extension, to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis (4 p.m. to 5 p.m.)

Biophytis SA BPTS announced that it will host a virtual key opinion leader event on its lead projects, Sarconeos (BIO101) for the treatment of COVID-19 and sarcopenia. The event is scheduled between 5:30 p.m. to 7:30 p.m.