The Daily Biotech Pulse: Sanofi, Regeneron Finalize Praluent Restructuring, Natus Pre-Announces Q1 Shortfall, Alcon To Delay Dividend Initiation

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

Scaling The Peaks

(Biotech stocks that hit 52-week highs April 6.)

• Forty Seven Inc FTSV
• Masimo Corporation MASI
• Seattle Genetics, Inc. SGEN
• Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Biotech stocks that hit 52-week lows April 6)

• BIOLASE Inc BIOL
• China SXT Pharmaceuticals Inc SXTC
• ENDRA Life Sciences Inc NDRA
• Global Cord Blood Corp CO
• ImmuCell Corporation ICCC
• IMMURON LTD/S ADR IMRN
• Menlo Therapeutics Inc MNLO (flunked two late-stage studies that evaluated oral serlopitant for treating pruritus associated with prurigo nodularis)
• Merus NV MRUS
• Millendo Therapeutics Inc MLND (said it is discontinuing development of livoletide as a potential treatment for Prader-Willi syndrome following failed Phase 2b study)
• Obalon Therapeutics Inc OBLN
• Quest Diagnostics Inc DGX (said it has performed 550,000 COVID-19 tests)
• Second Sight Medical Products Inc EYES

Stocks In Focus

Sanofi, Regeneron Finalize Previously Announced Praluent Restructuring

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN announced they have finalized the planned restructuring related to cholesterol drug Praluent. Effective April 1, Sanofi will have the sole responsibility for Praluent outside the U.S., while Regeneron assumes the sole responsibility in the U.S. The companies entered into an agreement to support manufacturing needs in the near term.

The intention to restructure the antibody collaboration was announced in December 2019. 

Crinetics Reports Positive Results In Midstage Study Of Paltusotine 

Crinetics Pharmaceuticals Inc CRNX announced positive interim results from the ongoing ACROBAT Edge Phase 2 trial that is evaluating the safety and efficacy of paltusotine in patients with acromegaly who have not achieved normal IGF-1 levels despite stable therapy with a somatostatin receptor ligands, or SRL, or with a SRL in combination with a dopamine agonist.

The company said enrollment in the ACROBAT Edge study is complete, with topline data expected in the fourth quarter of 2020.

The company also said it plans to advance paltusotine for acromegaly into Phase 3 trials in the first half of 2021 and into Phase 2 trials for patients with neuroendocrine tumors who suffer from carcinoid syndrome.

See also: The Week Ahead In Biotech: Spotlight On Q1 Pre-Announcements As COVID-19 Continues To Disrupt Operations

AIM ImmunoTech To Test Ampligen Delivery Using Vaping Device For Coronavirus In China

AIM ImmunoTech Inc AIM said it has entered into a material transfer and research agreement with vaping device maker Shenzhen Smoore Technology to research in China the efficacy of Smoore's inhalation delivery device using Ampligen.

Ampligen is AIM's lead drug which has been approved for myalgic encephalomyelitis and chronic fatigue syndrome in Argentina.

AIM said it believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19 caused by the new coronavirus, as it has yielded 100% protective efficacy against SARS-CoV-1 viral infection in duplicate experiments using a mouse model in U.S.

The stock was down 0.35% at $2.84 in Tuesday's premarket session. 

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Natus Lowers Q1 Revenue Guidance Due To COVID-19 Impact

Natus Medical Inc NTUS announced preliminary first-quarter revenue of $109 million to $110 million, lower than its previous guidance of $113 million to $117 million. The company blamed the shortfall relative to the guidance to the COVID-19 pandemic. The company also withdrew its 2020 guidance.

In premarket trading Tuesday, the stock was slipping 2.17% to $22.25.

Announcements On COVID-Related Impacts

Alcon AG ALC said it is withdrawing its 2020 guidance. The company also said it has withdrawn the dividend proposal to be discussed at its May 6 annual general meeting. The company plans to delay dividend initiation until 2021.

The stock was down 1.41% at $51.58 in Tuesday's premarket session. 

Morphosys Ag MOR said it is temporarily pausing enrollment and screening of patients in the M-PLACE study with MOR202. The company said it plans to continue enrollment of patients in studies with the potential for significant benefit in life-threatening conditions.

As of now, the company said it is maintaining its previously communicated 2020 guidance with respect to corporate milestones.

Zimmer Biomet Holdings Inc ZBH lowered its first-quarter revenue growth guidance to negative 9.5%-10.5%, citing a significant and sudden decline in elective procedure volume due to the COVID-19 pandemic. Analysts, on average, currently expect a 2.7% year-over-year revenue decline. The company also withdrew its full-year guidance.

Penumbra Inc PEN pre-announced first-quarter revenue of $137 million to $137.3 million, below the consensus estimate of $138.08 million. The company also withdrew its guidance.

On The Radar

Earnings

• AngioDynamics, Inc. ANGO (after the close)

Related Link: Co-Diagnostics COVID-19 Test Gets FDA Emergency Use Authorization