The Daily Biotech Pulse: Moderna's Vaccine Produces Durable Response Against Variants, FDA Approves Jazz's Sleep Disorder Drug, Dermata 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 Aug. 12)

• Adagio Therapeutics, Inc. ADGI (IPOed Aug. 6)
• Alkermes plc ALKS
• Bio-Rad Laboratories, Inc. BIO
• Candel Therapeutics, Inc. CADL (IPOed July 26)
• Century Therapeutics, Inc. IPSC (reacted to its second-quarter results)
• Dynavax Technologies Corporation DVAX
• Gilead Sciences, Inc. GILD
• Harvard Bioscience, Inc. HBIO
• Ironwood Pharmaceuticals, Inc. IRWD
• Innoviva, Inc. INVA
• Johnson & Johnson JNJ
• Sesen Bio, Inc. SESN
• Tenaya Therapeutics, Inc. TNYA (IPOed July 30)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 12)

• ABVC BioPharma, Inc. ABVC (announced its second-quarter results)
• ACADIA Pharmaceuticals Inc. ACAD
• Achilles Therapeutics plc ACHL
• Aeglea BioTherapeutics, Inc. AGLE
• Akero Therapeutics, Inc. AKRO
• Allogene Therapeutics, Inc. ALLO
• Alzamend Neuro, Inc. ALZN
• Aprea Therapeutics, Inc. APRE (announced that FDA imposed clinical hold on lymphoid malignancy study)
• Arena Pharmaceuticals, Inc. ARNA
• Aridis Pharmaceuticals, Inc. ARDS (announced second-quarter results)
• Atai Life Sciences N.V. ATAI (announced setting up of a subsidiary for studying Salvinorin A for mental health disorders)
• Axsome Therapeutics, Inc. AXSM
• Aytu Biopharma, Inc. AYTU
• Baudax Bio, Inc. BXRX
• Baxter International Inc. BAX
• Biodesix, Inc. BDSX
• Biomea Fusion, Inc. BMEA
• Cellectar Biosciences, Inc. CLRB
• Celularity Inc. CELU
• Codex DNA, Inc. DNAY
• CytomX Therapeutics, Inc. CTMX
• DiaMedica Therapeutics Inc. DMAC (reacted to its second-quarter results)
• Dicerna Pharmaceuticals, Inc. DRNA
• Edgewise Therapeutics, Inc. EWTX
• Ensysce Biosciences, Inc. ENSC
• Epizyme, Inc. EPZM
• Exicure, Inc. XCUR (announced its second-quarter results)
• EyeGate Pharmaceuticals, Inc. EYEG
• FibroGen, Inc. FGEN
• Flexion Therapeutics, Inc. FLXN
• Grifols, S.A. GRFS
• Heron Therapeutics, Inc. HRTX
• HOOKIPA Pharma Inc. HOOK (reacted to its second-quarter result)
• Hoth Therapeutics, Inc. HOTH
• IMARA Inc. IMRA
• IN8bio, Inc. INAB
• Incyte Corporation INCY
• Inhibikase Therapeutics, Inc. IKT
• iRhythm Technologies, Inc. IRTC
• Karyopharm Therapeutics Inc. KPTI
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kronos Bio, Inc. KRON
• Lava Therapeutics B.V. LVTX
• Liminal BioSciences Inc. LMNL
• Lumos Pharma, Inc. LUMO
• MediciNova, Inc. MNOV
• Moleculin Biotech, Inc. MBRX (reacted to its second-quarter results)
• Nektar Therapeutics NKTR
• Neurocrine Biosciences, Inc. NBIX
• Orchard Therapeutics plc ORTX
• Panbela Therapeutics, Inc. PBLA (announced its second-quarter results)
• Passage Bio, Inc. PASG
• PharmaCyte Biotech, Inc. Common Stock PMCB
• Praxis Precision Medicines, Inc. PRAX
• Progenity, Inc. PROG
• Protara Therapeutics, Inc. TARA
• Rapid Micro Biosystems, Inc. RPID
• Revolution Medicines, Inc. RVMD (announced its second-quarter results)
• Rockwell Medical, Inc. RMTI
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Spruce Biosciences, Inc. SPRB
• Teligent, Inc. TLGT
• TFF Pharmaceuticals, Inc. TFFP
• TherapeuticsMD, Inc. TXMD
• Trevena, Inc. TRVN (reacted to its second-quarter results)
• Trillium Therapeutics Inc. TRIL
• VectivBio Holding AG VECT
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE ( announced its quarterly results and in-licensing of a platform for immuno-inflammatory conditions)
• Zealand Pharma A/S ZEAL
• ZIOPHARM Oncology, Inc. ZIOP
• Zogenix, Inc. ZGNX
• ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Jazz' Sleep Disorder Drug Approved By The FDA

Jazz Pharmaceuticals, Inc. JAZZ said the Food and Administration approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.

The company said it plans to make Xywav available to patients with idiopathic hypersomnia later this year following Risk Evaluation and Mitigation Strategies implementation.

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

Moderna's COVID-19 Vaccine Was Found Effective Against Variants For Six Months After Second Dose

Moderna, Inc. MRNA announced the publication of new data on the durability of the Moderna COVID-19 vaccine in generating neutralizing antibodies against variants of concern. The manuscript was published in ‘Science, showed the majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose.

The variants studies included alpha, beta, gamma, delta, epsilon and Iota.

The stock was up 1.43% at $397 in premarket trading.

FDA Issues Third Authorizations For Pfizer/BioNTech and Moderna Vaccines For Use In Immunocompromised Individuals

The FDA expanded ethe emergency use authorizations for vaccines from both the Pfizer, Inc. PFE-BioNTech SE BNTX COVID-19 Vaccine and the Moderna COVID-19 vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals.

BioNTech shares were up 2.28% at $382.54 in premarket trading and Pfizer was edging up 0.13% to $47.30.

Myovant Names Uneek Mehra as CFO

Myovant Sciences MYOV announced the appointment of Uneek Mehra as chief financial and business officer, succeeding Frank Karbe, who has decided to pursue other opportunities.

Beginning Sept. 7, Mehra will lead Myovant's finance, alliance partnerships, and business development functions and will be a member of Myovant's Executive Committee, reporting to Dave Marek, Myovant's CEO, the company added.

Harpoon Shares Rise On Insider Buying

Harpoon Therapeutics, Inc. HARP said in a filing Ronald Hunt, a director of the company's board, bought 235,294 shares in the company at $17 apiece. A separate filing also showed that New Leaf Ventures III, which holds a 10% stake in the company, also bought 235,294 shares at the same price.

The stock was up 4.80% at $9.39 in premarket trading.

Fusion Pharma to Collaborate With Canada's TRIUMF For Actinium-225

Fusion Pharmaceuticals, Inc. FSUN and TRIUMF, Canada's particle accelerator centre, announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225.
Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.

The shares were down 1.96% at $8.01 in premarket trading.

Earnings

BIOLASE, Inc. BIOL said its second-quarter revenues climbed 2.11% to $9.1 million. The company reported break-even results as opposed to the loss of 12 cents per share a year earlier. The results exceeded estimates.

The stock was jumping 34.93% to 85 cents in premarket trading.

Co-Diagnostics, Inc. CODX's second-quarter revenues climbed 13.8% to $27.4 million, thanks to strong COVID-19 test sales. The earnings per share fell from 51 cents to 33 cents.

The company guided third-quarter EPS to 19-22 cents and revenues to $23 million to $25 million.

The results as well as the guidance exceeded expectations.

In premarket trading, the stock was up 6.83% at $10.33 in premarket trading.

Capricor Therapeutics, Inc. CAPR reported a strong increase in revenues and a narrower loss for the second quarter.

The stock was down 11.83% at $3.95 in premarket trading.

On The Radar

Earnings

Medicenna Therapeutics Corp. MDNA (before the market open)
GT Biopharma, Inc. GTBP (before the market open)
Forma Therapeutics Holdings, Inc. FMTX (before the market open)
Bio-Path Holdings, Inc. BPTH (before the market open)
Alimera Sciences, Inc. ALIM (before the market open)
Iterum Therapeutics plc ITRM (before the market open)
Jaguar Health, Inc. JAGX (before the market open)
23andMe Holding Co. ME (before the market open
HCW Biologics Inc. HCWB (before the market open)
Trillium Therapeutics Inc. (TRIL) (before the market open)

IPO

Dermata Therapeutics, Inc. DRMA, a clinical-stage medical dermatology company priced its initial public offering of 2.571 million shares of its common stock and accompanying warrants to purchase up to 2.571 million shares of common stock.

Each share of common stock is being sold together with one warrant to purchase one share of common stock with an exercise price of $7 per share at a combined offering price of $7, for gross proceeds of approximately $18 million.

The shares of common stock and warrants are expected to begin trading on the Nasdaq under the symbols "DRMA" and "DRMAW," respectively.