FDA Approval for TYRVAYA issued to OYSTER POINT PHARMA INC

10/19/21 7:27:01 PM ET

$OYST

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 213978
Company: OYSTER POINT PHARMA INC

Products on NDA 213978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYRVAYA	VARENICLINE	0.6MG/ML	SPRAY; NASAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$OYST

Date	Price Target	Rating	Analyst
8/11/2022	$22.00	Buy	Chardan Capital Markets
7/18/2022	$20.00	Buy	H.C. Wainwright
11/9/2021	$30.00 → $23.00	Overweight → Neutral	JP Morgan

More analyst ratings

FDA Approval for TYRVAYA issued to OYSTER POINT PHARMA INC

10/19/21 7:27:01 PM ET

$OYST

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $OYST alert in real time by email

New Drug Application (NDA): 213978
Company: OYSTER POINT PHARMA INC

Products on NDA 213978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYRVAYA	VARENICLINE	0.6MG/ML	SPRAY; NASAL	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$OYST

Date	Price Target	Rating	Analyst
8/11/2022	$22.00	Buy	Chardan Capital Markets
7/18/2022	$20.00	Buy	H.C. Wainwright
11/9/2021	$30.00 → $23.00	Overweight → Neutral	JP Morgan

More analyst ratings

$OYST
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Oyster Point Pharma, Inc., Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., Dec. 02, 2022 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc., (NASDAQ:OYST), ("Oyster Point Pharma", or "the Company"), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced that the Compensation Committee of the Company's Board of Directors granted inducement non-qualified stock options to purchase an aggregate of 11,300 shares of common stock to three new employees, pursuant to the Oyster Point Pharma, Inc., 2021 Inducement Incentive Plan. Each stock option has an exercise price equal to $11.20 per share, Oyster Point Pharma's

12/2/22 8:00:00 AM ET

$OYST

Biotechnology: Pharmaceutical Preparations

Health Care

Lifshitz Law PLLC Announces Investigations of RBA, OYST, LFG, and IAA

NEW YORK, NY / ACCESSWIRE / November 12, 2022 / Ritchie Bros. Auctioneers Incorporated (NYSE:RBA)Lifshitz Law PLLC announces an investigation into possible breach of fiduciary duties in connection with the sale of IAA, Inc. to RBA for $10.00 per share in cash and 0.5804 shares of RBA common stock for each share of IAA common stock.If you are an RBA investor, and would like additional information about our investigation, please complete the Information Request Form or contact Joshua Lifshitz, Esq. by telephone at (516)493-9780 or email at [email protected] Point Pharma, Inc. (NASDAQ:OYST)Lifshitz Law PLLC announces an investigation into possible breach of fiduciary duties in connecti

11/12/22 8:11:00 PM ET

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Oyster Point Pharma Reports Third Quarter 2022 Financial Results and Recent Business Highlights

TYRVAYA® (Varenicline Solution) Nasal Spray Achieved Net Product Revenue of $5.6 Million in Q3'22Approximately 34,000 TYRVAYA Prescriptions Filled During the Quarter, with Prescriptions Written by Approximately 6,100 Unique Eye Care ProfessionalsNovember 1, 2022 Marked the First Anniversary of the Commercial Launch of TYRVAYA, with Over 97,000 Prescriptions Written as of October 21, 2022Expanded Patient Access and Commercial Coverage for TYRVAYA, with Up to Approximately 117 Million Lives Covered to DateOyster Point Pharma to be Acquired by Viatris, with the Transaction Expected to Close During Q1'23Enrollment Completed in the OLYMPIA Phase 2 Clinical Trial for Stage 1 Neurotrophic Keratopat

11/10/22 4:05:00 PM ET

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Leadership Updates

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Oyster Point Pharma Announces Retirement of William J. Link From Board of Directors

PRINCETON, N.J., March 17, 2022 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced that William J. Link, Ph.D., is retiring from Oyster Point's Board of Directors, effective as of March 17, 2022. Dr. Link will continue to serve as a consultant to the company. "On behalf of the entire Oyster Point organization, we are eternally thankful to Dr. Link for his leadership and significant contributions over the years," said Jeffrey Nau, M.M.S, Ph.D., president and chief executive officer, Oy

3/17/22 8:00:00 AM ET

$OYST

Biotechnology: Pharmaceutical Preparations

Health Care

Oyster Point Pharma Announces New Chairperson Appointment to Board of Directors

PRINCETON, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced the appointment of a new Director and Chairperson to its Board of Directors. The Oyster Point Pharma Board of Directors is pleased to announce the appointment of Donald Santel as non-executive Chairperson and a Director of the Company and a member of the Compensation Committee. Don joined the Board on July 30, 2021, and will take over as Chairperson as Ali Behbahani, M.D. steps down as Chairperson, remaining a

8/2/21 4:01:00 PM ET

$OYST

Biotechnology: Pharmaceutical Preparations

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Oyster Point Pharma Strengthens Executive Leadership Team with the Appointment of Chief Medical and Chief Scientific Officers

PRINCETON, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced the appointment of Marian Macsai, M.D., as Chief Medical Officer, and Eric Carlson, Ph.D., as Chief Scientific Officer, both of whom will join the executive leadership team, effective December 7, 2020. “I’m thrilled to welcome Drs. Macsai and Carlson to the executive leadership team at Oyster Point, as both will help expand and strengthen our organization during this time of unprecedented growth,” said

12/7/20 7:00:00 AM ET

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Biotechnology: Pharmaceutical Preparations

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Oyster Point Pharma Reports Third Quarter 2022 Financial Results and Recent Business Highlights

11/10/22 4:05:00 PM ET

$OYST

$VTRS

Biotechnology: Pharmaceutical Preparations

Health Care

Oyster Point Pharma, a Leading Ophthalmology-Focused Biopharmaceutical Company, to be Acquired by Viatris

Tender Offer to Acquire All Outstanding Shares of Oyster Point Pharma for $11.00 per Share, Plus a Contingent Value Right of Up To $2.00 per Share PRINCETON, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), ("Oyster Point Pharma"), today announced that it has entered into a definitive agreement under which Viatris Inc. (NASDAQ:VTRS), a global healthcare company, would acquire Oyster Point Pharma, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. Viatris intends to acquire Oyster Point Pharma as the foundation of its new ophthalmolo

11/7/22 8:00:00 AM ET

$OYST

$VTRS

Biotechnology: Pharmaceutical Preparations

Health Care

Oyster Point Pharma To Report Third Quarter 2022 Financial Results On November 10, 2022

PRINCETON, N.J., Nov. 02, 2022 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST) a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced that it will report third quarter 2022 financial results on Thursday, November 10, 2022, after the market close. The announcement will be followed by a live audio webcast and conference call at 4:30 p.m. Eastern Time. Conference Call DetailsTo access the live call by phone, please register here to receive dial-in details or to select a call back. Webcast DetailsThe webcast will be made available on the compa

11/2/22 4:02:00 PM ET

$OYST

Biotechnology: Pharmaceutical Preparations

Health Care

FDA Approval for TYRVAYA issued to OYSTER POINT PHARMA INC

Products on NDA 213978

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213978

Original Approvals or Tentative Approvals

Crush Q3 2025 with the Best AI Superconnector

Recent Analyst Ratings for $OYST

FDA Approval for TYRVAYA issued to OYSTER POINT PHARMA INC

Products on NDA 213978

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213978

Original Approvals or Tentative Approvals

Crush Q3 2025 with the Best AI Superconnector

Recent Analyst Ratings for $OYST

$OYST Insider Trading

SEC Form 4 filed by Invopps Gp Iv, L.L.C.

SEC Form 4 filed by Versant Venture Capital Vi, L.P.

SEC Form 4: Behbahani Ali returned 13,639 shares to the company, closing all direct ownership in the company (for tax liability)

$OYST Analyst Ratings

Chardan Capital Markets initiated coverage on Oyster Point Pharma with a new price target

H.C. Wainwright initiated coverage on Oyster Point Pharma with a new price target

Oyster Point Pharma downgraded by JP Morgan with a new price target

$OYST Press Releases

Oyster Point Pharma, Inc., Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Lifshitz Law PLLC Announces Investigations of RBA, OYST, LFG, and IAA

Oyster Point Pharma Reports Third Quarter 2022 Financial Results and Recent Business Highlights

$OYST SEC Filings

SEC Form 15-12G filed by Oyster Point Pharma Inc.

SEC Form EFFECT filed by Oyster Point Pharma Inc.

$OYST FDA approvals