The Daily Biotech Pulse: Lilly, Morphic's Positive Data At ECCO, Humanigen's COVID Treatment Gets Expedited Review In UK, TransCode IPO

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 July 8)

• Aerpio Pharmaceuticals, Inc. ARPO (moved on positive analyst action)
• Ambrx Biopharma Inc. AMAM
• AtriCure, Inc. ATRC
• Biohaven Pharmaceutical Holding Company Ltd. BHVN
• BioLife Solutions, Inc. BLFS
• Edwards Lifesciences Corporation EW
• Novo Nordisk A/S NVO
• Recursion Pharmaceuticals, Inc. RXRX
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 8)

• 89bio, Inc. ETNB
• AbCellera Biologics Inc. ABCL
• Achilles Therapeutics plc ACHL
• Adicet Bio, Inc. ACET
• ADMA Biologics, Inc. ADMA
• Aerovate Therapeutics, Inc. AVTE (IPOed June 30)
• Agile Therapeutics, Inc. AGRX
• Akero Therapeutics, Inc. AKRO (announced positive Phase 2 data for non-alcoholic steatohepatitis drug)
• Allogene Therapeutics, Inc. ALLO
• AlloVir, Inc. ALVR
• Aptose Biosciences Inc. APTO
• Assembly Biosciences, Inc. ASMB
• Ayala Pharmaceuticals, Inc. AYLA
• Aytu Biopharma, Inc. AYTU
• Aziyo Biologics, Inc. AZYO
• Baudax Bio, Inc. BXRX
• Biophytis SA BPTS
• BioXcel Therapeutics, Inc. BTAI
• Black Diamond Therapeutics, Inc. BDTX
• Bolt Biotherapeutics, Inc. BOLT
• Calithera Biosciences, Inc. CALA
• CASI Pharmaceuticals, Inc. CASI
• Cellectis S.A. CLLS
• Celyad Oncology SA CYAD
• Cerus Corporation CERS
• Chembio Diagnostics, Inc. CEMI
• Cidara Therapeutics, Inc. CDTX
• Concert Pharmaceuticals, Inc. CNCE
• Cogent Biosciences, Inc. COGT
• CytomX Therapeutics, Inc. CTMX
• CVRx, Inc. CVRX (IPOed June 30)
• Design Therapeutics, Inc. DSGN
• DURECT Corporation DRRX
• Ensysce Biosciences, Inc. ENSC
• Exelixis, Inc. EXEL
• Exicure, Inc. XCUR
• Galapagos NV GLPG
• Galecto, Inc. GLTO
• Gemini Therapeutics, Inc. GMTX
• GlycoMimetics, Inc. GLYC
• Inhibikase Therapeutics, Inc. IKT
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA
• Kiromic BioPharma, Inc. KRBP
• LogicBio Therapeutics, Inc. LOGC
• Lyell Immunopharma, Inc. LYEL
• Medicenna Therapeutics Corp. MDNA
• MediciNova, Inc. MNOV
• Mersana Therapeutics, Inc. MRSN
• Miromatrix Medical Inc. MIRO
• Molecular Templates, Inc. MTEM
• MorphoSys AG MOR
• Nabriva Therapeutics plc NBRV
• Neoleukin Therapeutics, Inc. NLTX
• NexImmune, Inc. NEXI
• NRx Pharmaceuticals, Inc. NRXP
• Osmotica Pharmaceuticals plc OSMT
• Otonomy, Inc. OTIC
• Pharvaris N.V. PHVS
• Rockwell Medical, Inc. RMTI
• Sensei Biotherapeutics, Inc. SNSE
• Sigilon Therapeutics, Inc. SGTX
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Taysha Gene Therapies, Inc. TSHA
• Tempest Therapeutics Inc. TPST
• uniQure N.V. QURE
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE
• Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Cyclerion Inks Partnership With Beacon For Identifying Biomarkers to Be Used In Clinical Development of Neurologic Disease Treatments

Cyclerion Therapeutics, Inc. CYCN announced an extended and expanded strategic partnership with Beacon Biosignals to assist in identifying disease-relevant biomarkers to refine patient selection and endpoints to aid clinical development of Cyclerion's investigational therapeutics for neurological diseases associated with cognitive impairment.

"Beacon Biosignals is the leader in the identification of disease-relevant EEG neurological biomarkers. We believe that the application of this technology to our innovative pipeline may be quite powerful in guiding efficient drug development, and we look forward to a productive partnership focused on successfully advancing CY6463 for diseases associated with cognitive impairment," said Andy Busch, chief scientific officer of Cyclerion.

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

Humanigen's COVID-19 Treatment Accepted For Expedited Review In U.K.

Humanigen, Inc. HGEN announced its submission for marketing authorization for lenzilumab in COVID-19 that begun in June 2021, has been accepted by the U.K.'s Medicines and Healthcare Products Regulatory Agency for expedited COVID-related rolling review.

The stock was adding 13.57% to $18.91 in premarket trading.

BeiGene Gets Chinese Regulatory Nod For Cancer Drug Licensed From Amgen

BeiGene, Ltd. BGNE announced that the China National Medical Products Administration has conditionally approved Kyprolis for injection in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.

Kyprolis is licensed to BeiGene in China under a strategic collaboration with Amgen, Inc. AMGN.

Ovid Appoints Former AstraZeneca Executive to Board, Announces New Executive Appointments

Ovid Therapeutics Inc. OVID announced the appointment of Jason Tardio and Claude Nicaise as chief operating officer and Head of R&D, respectively.

The company also announced Dr. Amit Rakhit will leave Ovid's full-time management team at the end of August and will join its Scientific and Clinical Advisory Board.

Ovid said Dr. Michael Poole, a neurologist and internist who has held scientific and leadership roles over a 30-year career spanning large and small biotechnology companies, will join its board. Poole has served as VP and Head of Neuroscience Innovation at AstraZeneca plc AZN, it added.

"The changes are part of a broad initiative to reshape Ovid to achieve its strategic goals and advance next-generation medicines that transform the lives of people with intractable, rare neurological diseases," the company said.

Morphic Announces Positive Early-stage Data For MORF-057 In Inflammatory Bowel Disease

Morphic Holding, Inc. MORF announced positive results from its full phase 1 clinical trial for MORF-057, an oral small molecule inhibitor of the α4β7 integrin in development for the treatment of inflammatory bowel disease.

"The complete phase 1 clinical data set including a favorable safety profile, predictable PK and excellent PD results, confirm MORF-057 as a very strong candidate for oral therapy in inflammatory bowel disease," the company said.

The data were shared in an ePoster presentation at the Congress of European Crohn's and Colitis Organisation, or ECCO, 2021 Virtual Congress.

Lilly Says Mirikizumab Found Effective For Up to 1 Year In Mid-stage Ulcerative Colitis Study

Eli Lilly and Company LLY announced new Phase 2 data showing that gene expression changes induced by mirikizumab in patients with ulcerative colitis over a 12-week induction treatment were maintained for up to one year.

These gene transcript changes, which were unique among those who responded to mirikizumab compared to placebo, were associated with mucosal healing, indicating that mirikizumab affects a distinct molecular healing pathway, compared to the spontaneous healing that occurred among those who responded to placebo, the company added.

Mirikizumab is being studied in Phase 3 trials for UC and Crohn's disease, two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life.

These results are being presented virtually at the ECCO 2021 virtual congress.

On The Radar

Clinical Readouts

Pharvaris will present clinical data for oral PHA121 that is being evaluated for the treatment of hereditary angioedema, as an e-Poster at the European Academy of Allergy and Clinical Immunology, Annual Congress. The abstract will be published on the EAACI website on Saturday, July 10. The virtual poster presentation will be on the EAACI website from July 10-16.

IPO

TransCode Therapeutics, Inc., a RNA oncology company, priced its initial public offering of 6.25 million shares at $4 per share, for gross proceeds of $25 million. All of the shares of common stock are being offered by the company.
The company said it intends to use the proceeds for testing required to file an IND for the Phase 0 trial of TTX-MC138, for further development of TTX-MC138, strategic expansion of their drug candidate portfolio, and the balance for working capital and general corporate purposes.
The shares are expected to begin trading on the Nasdaq under the symbol "RNAZ."