The Daily Biotech Pulse: KemPharm Receives $10M Milestone Payment, Zymergen, Neuropace Debut On Nasdaq, Renalytix Wins US Government Contract, 2 IPOs

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 April 21)

• Alexion Pharmaceuticals, Inc. ALXN
• Axonics, Inc. AXNX
• BioNTech SE BNTX
• Bio-Techne Corporation TECH
• Boston Scientific Corporation BSX
• Edwards Lifesciences Corporation EW (reacted to better-than-expected quarterly results)
• Globus Medical, Inc. GMED
• Integra LifeSciences Holdings Corporation IART
• Intuitive Surgical, Inc. ISRG (announced better-than-expected quarterly results)
• MacroGenics, Inc. MGNX
• Medtronic plc MDT (announced Food and Drug administration approval for Flex Embolization Device with Shield Technology)
• Merit Medical Systems, Inc. MMSI
• PRA Health Sciences, Inc. PRAH
• Prometheus Biosciences, Inc. RXDX
• Recursion Pharmaceuticals, Inc. RXRX (went public Friday)
• ShockWave Medical, Inc. SWAV
• Syneos Health, Inc. SYNH
• United Therapeutics Corporation UTHR
• West Pharmaceutical Services, Inc. WST
• Zimmer Biomet Holdings, Inc. ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 21)

• Aprea Therapeutics, Inc. APRE
• Axsome Therapeutics, Inc. AXSM
• ChemoCentryx, Inc. CCXI
• Design Therapeutics, Inc. DSGN
• Emergent BioSolutions Inc. EBS
• Enveric Biosciences, Inc. ENVB
• Evofem Biosciences, Inc. EVFM
• Epizyme, Inc. EPZM
• Finch Therapeutics Group, Inc. FNCH
• Galera Therapeutics, Inc. GRTX
• Gracell Biotechnologies Inc. GRCL
• Haemonetics Corporation HAE
• Hoth Therapeutics, Inc. HOTH
• Instil Bio, Inc. TIL
• Longboard Pharmaceuticals, Inc. LBPH
• Longeveron Inc. LGVN
• Millendo Therapeutics, Inc. MLND
• Moleculin Biotech, Inc. MBRX
• Vaxcyte Inc PCVX
• VectivBio Holding AG VECT
• Vyne Therapeutics Inc VYNE

Stocks In Focus

KemPharm Receives $10M Milestone Payment Related To FDA Approval Of ADHD Drug

KemPharm, Inc. KMPH announced the receipt of a regulatory milestone payment of $10 million for the FDA approval of Azstarys in accordance with the recently amended definitive collaboration and license agreement with Commave Therapeutics, an affiliate of Gurnet Point Capital.

Corium, Inc., a portfolio company of Gurnet Point Capital, is leading U.S. commercialization efforts for Azstarys.

Azstarys is a once-daily product for the treatment of attention deficit hyperactivity disorder in patients age six years and older and consists of serdexmethylphenidate, KemPharm's prodrug of d-methylphenidate, co-formulated with immediate-release d-MPH.

The stock was up 1.35% premarket at $9.04. 

PRA Health Expands Pharmacovigilance Solution To COVID-19 Vaccines, Therapies

PRA Health announced the expansion of its pharmacovigilance solution to offer full post-marketing services for authorized COVID-19 vaccines and therapeutics, including post-authorization safety studies, delivered by real world solutions.

"With more than 25 years of experience executing comprehensive pharmacovigilance and patient safety services in all key therapeutic areas including infectious diseases, PRA can work closely with drug developers and manufacturers in ensuring long-term safety and efficacy of COVID-19 vaccines and treatments," the company said.

Glaukos Expands In-Licensing Agreement For Eyelid Drug Delivery Platform For Additional Indication

Glaukos Corporation GKOS announced that it has entered into an amended licensing agreement with Intratus under which Intratus has granted Glaukos a global exclusive license for its patented Eyelid Drug Delivery Platform for application in the treatment of presbyopia.

The original agreement applied to the use of the platform for the treatment of dry eye disease, glaucoma and other corneal disorders such as allergy, blepharitis, conjunctivitis and related conditions.

Renalytix Gets 10-Year Government Contract For Early Stage Kidney Disease Testing Services

Renalytix AI plc RNLX announced that the U.S. government has granted the company a 10-year Governmentwide Acquisition Contract to provide KidneyIntelX early stage kidney disease bioprognostic testing services.

The contract, offered through the General Services Administration, covers laboratory testing services that can be provided through more than 140 U.S. government departments, agencies and affiliates.

The contract is effective as of April 15 and has a five-year term with a five-year extension option. It's structured as an Indefinite Delivery, Indefinite Quantity contract providing for an unlimited quantity of services over the contract term.

Under the contract, KidneyIntelX pricing is set at $950 per reportable result.

The shares were jumping 20.86% to $40.38 in premarket trading Thursday.

Related Link: The Week Ahead In Biotech: Johnson & Johnson, Biogen Earnings, Neurology Conference And IPOs

Yumanity Says Lead Drug Produced Target Engagement In Phase 1a Study

Yumanity Therapeutics YMTX reported that its lead product candidate, YTX-7739, which is in development for the treatment of Parkinson's disease, demonstrated dose-dependent decreases in target fatty acids.

This can be interpreted as evidence of in vivo target engagement in a Phase 1a multiple ascending dose clinical trial in healthy volunteers.

Inhibition of stearoyl-CoA desaturase has been shown to improve motor function and other disease markers in transgenic mouse models of Parkinson's disease. YTX-7739 was also observed to be generally well tolerated in the Phase 1a study, the company said.

Lexaria Commences Human Study Of Cannabidiol Formulation In Hypertension

Lexaria Bioscience Corp. LEXX announced that its human clinical hypertension study HYPER-H21-1 is underway. The study will assess its patented DehydraTECH CBD formulation for its ability to control blood pressure and its impact on inflammation.

Orthofix Announces FDA Clearance For 3D-Printed Interbody Implant

Orthofix Medical, Inc. OFIX announced FDA 510(k) clearance and the first patient implant of the Forza Ti TLIF Spacer System to help optimize Transforaminal Lumbar Interbody Fusion procedures.

The spacer, with Nanovate Technology, is a titanium 3D-printed interbody featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer.

Interbody implants are spacers that surgeons insert between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs.

Offerings

Evolus, Inc. EOLS priced its public offering of 9 million shares of its common stock at a price of $9.50 per share for raising gross proceeds of about $85.5 million.

The stock was down 16.81% premarket at $9.75. 

NeuBase Therapeutics, Inc. NBSE said it has commenced an underwritten public offering of shares of common stock. All of the shares of common stock in the offering will be sold by NeuBase.

The stock was down 14.5% premarket at $5.13.

On The Radar

Earnings

• Biogen Inc. BIIB (before the market open)
• Quest Diagnostics Incorporated DGX (before the market open)
• NeuroMetrix, Inc. NURO (before the market open)
• Plus Therapeutics, Inc. PSTV (after the close)

IPOs

Mountainview, California-based Neuropace Inc. priced its upsized initial public offering of 6 million shares at $17, the upper end of the estimated price range of $15-$17. Gross proceeds from the offering are expected at $102 million.

The commercial-stage medical device company, which manufactures a brain-responsive neuromodulation system for epilepsy treatment, said its shares will begin trading on the Nasdaq under the ticker symbol "NPCE."

Zymergen Inc, an Emeryville, California-based biofacturing company that engineers microbes to make novel biomolecules used in different products, priced its upsized IPO of 16.13 million shares at $31 versus the estimated price range of $28-$31. The company's shares will begin on the Nasdaq under the ticker symbol "ZY."

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