iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB), Abeona Therapeutics Inc (NASDAQ: ABEO)


Here is an overview of the main developments in the field of biotechnology over the past 24 hours.

Climb the summits

(Biotech stocks hit 52-week highs on October 5)

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

In landfills

(Biotech stocks hit 52-week lows on October 5)

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

Click here to access Benzinga’s FDA calendar

Focus on actions

Takeda Suspends Two Phase 2 Studies of Sleep Disorders Treatment Candidate Due to Safety Alert

Takeda Pharmaceuticals Company Limited (NYSE: TAK) said a safety signal has emerged in Phase 2 studies of TAK-994, an experimental oral orexin agonist that is being evaluated for narcolepsy. As an immediate precautionary measure, the company has suspended the dosage of the patients and decided to prematurely end the two phase 2 studies. This allows the benefit / risk profile of TAK-994 to be interpreted in a timely manner and to determine the next ones. stages of the program.

“We are working to rapidly assess all of the available data to inform further development of TAK-994,” the company said.

The stock lost 4.54% to $ 15.35 in pre-market.

Acer’s regulatory application for urea cycle disorder drug accepted for review

Acer Therapeutics Inc. (NASDAQ: ACER) and its collaboration partner Relief Therapeutics Holding AG (OTC: RLFTF) announced that the United States Food and Drug Administration has agreed to file the new drug application for ACER-001 for the treatment of patients with urea cycle disorders. The FDA has assigned a target action date for PDUFA as June 5, 2022.

Acer shares jumped 25.30% to $ 3.12 in pre-market trading.

Voyager signs license options agreement with Pfizer valued at up to $ 600 million

Voyager announced an agreement whereby Pfizer Inc (NYSE: PFE) may exercise options to license new capsids generated from Voyager’s RNA-based TRACER screening technology as part of Voyager’s efforts to develop, manufacture and commercialize gene therapies, using two undisclosed transgenes to treat certain neurological 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. Additionally, Voyager will be eligible to earn up to $ 580 million in total development, regulatory and commercial milestones associated with the licensed products.

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

In pre-market trading, Voyager shares climbed 43.73% to $ 3.55.

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

Kiromic announces the abrupt departure of its CFO

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

Surrozen Announces Positive Preclinical Data for Inflammatory Bowel Disease Control Program

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

“We believe SZN-1326 is well positioned to transform the paradigm for treating patients with IBD, including Crohn’s disease and ulcerative colitis,” said Craig Parker, President and CEO of Surrozen.

The stock was up 4.33% to $ 6.50 in pre-market.

RedHill Announces California Medicaid Medical Coverage For Treatment Of Bacterial Infections

RedHill Biopharma Ltd. (NASDAQ: RDHL) said that Medi-Cal – California’s Medicaid healthcare program covering two million patients – has added its Talicia to its list of contract drugs for the treatment of H. pylori, without prior authorization required, as of October 1.

Talicia’s coverage began for two million patients under Medi-Cal’s California FFS plan, the company added.

The stock rose 3.617% to $ 4.87 in pre-market.

On the radar

Clinical readings / presentations

Denali Therapeutics Inc. (NASDAQ: DNLI) to present at the 2021 Northeast Amyotrophic Lateral Sclerosis Annual Meeting data from a Phase 2 study, followed by a long-term open-label extension, to assess the efficacy and l Safety of SAR443820 in adult participants with muscular atrophy lateral sclerosis (4 p.m. to 5 p.m.)

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

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