KMPH - KMPH STOCK NEWS

KemPharm (NASDAQ: KMPH) announced a Letter to Shareholders regarding its upcoming 2021 Annual Meeting. The company reported key developments including FDA approval of AZSTARYS for ADHD treatment and a successful financial restructuring, eliminating all debt and increasing cash to $76 million, plus an additional $20 million in milestone payments. KemPharm is also set to be listed on the Russell 2000 and 3000 Indexes effective June 28, 2021. The classification of its prodrug serdexmethylphenidate as a Schedule IV substance enhances its market positioning.

KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company, is set to be included in the Russell 3000® and Russell 2000® indexes starting June 28, 2021. This milestone follows a year of significant achievements for the company, including FDA approval for its leading drug AZSTARYS™, successful financial transactions for Nasdaq uplisting, and debt elimination. KemPharm aims for this inclusion to enhance shareholder value, increase stock liquidity, and broaden its investor base, as Russell indexes are benchmarked by approximately $10.6 trillion in assets.

KemPharm, a specialty pharmaceutical company, announced participation in two significant panels addressing the impact of the COVID-19 pandemic. Travis C. Mickle, CEO, will discuss the regulatory climate on June 7, 2021, at the Consero Global IP Management Forum, while Christal Mickle, VP of Operations, will address biopharmaceutical industry challenges during BIO Digital 2021 on June 15, 2021. KemPharm is known for its LAT technology and developing prodrugs for conditions like ADHD and stimulant use disorder. For more information on KemPharm's initiatives and product candidates, visit their website.

KemPharm, Inc. (KMPH) announced that six U.S. patents for serdexmethylphenidate (SDX), the active ingredient in AZSTARYS™, are now listed in the FDA's Orange Book, confirming SDX's status as a new chemical entity (NCE). This designation grants at least five years of market exclusivity, protecting against generic competition. KemPharm aims to commercialize AZSTARYS, approved for ADHD treatment, and advance clinical programs for KP879. The patents include a composition patent expiring in 2032 and five others in 2037, providing substantial protection for their SDX-based products.

KemPharm reported a significant transformation in Q1 2021, highlighted by FDA approval of AZSTARYS on March 2, 2021, and successful financial restructuring resulting in $94 million in gross proceeds and a debt-free status. The company posted Q1 revenue of $12.1 million, primarily from a milestone payment, with a net loss of $10.3 million, or $0.54 per share. Cash holdings increased to $76 million. The license agreement with Gurnet Point Capital was amended to include up to $590 million in future milestone payments for AZSTARYS, enhancing shareholder value prospects.

KemPharm, Inc. (NASDAQ: KMPH) announced that its prodrug serdexmethylphenidate (SDX) has been classified as a Schedule IV controlled substance by the DEA. This classification is based on an analysis by HHS indicating lower abuse potential compared to d-methylphenidate. The decision enhances the market prospects for KemPharm’s KP879, aimed at treating stimulant use disorder (SUD), as it could also be designated as Schedule IV if approved. Additionally, KemPharm received a $10 million milestone payment related to SDX's scheduling determination.

KemPharm, a specialty pharmaceutical company, will host a conference call and live audio webcast on May 13, 2021, at 4:30 p.m. ET to discuss its first quarter 2021 corporate and financial results. Participants can join the call by dialing (866) 395-2480 for U.S. callers or (678) 509-7538 for international callers. The conference ID is 4737008. An audio webcast will be available on KemPharm’s Investor Relations website, and an archive will be accessible for 90 days post-event. Investors can submit questions via email prior to the call.

KemPharm, Inc. (NASDAQ: KMPH) has announced a $10 million regulatory milestone payment for FDA approval of AZSTARYS™, a once-daily ADHD treatment, following a license agreement with Commave Therapeutics. The potential for future milestone payments totals up to $590 million, with the next $10 million due after DEA scheduling of serdexmethylphenidate (SDX), expected by June 2, 2021. The commercial launch of AZSTARYS is targeted for the second half of 2021, with significant market uptake anticipated due to its unique product characteristics addressing unmet needs in ADHD treatment.

KemPharm, Inc. (NASDAQ: KMPH) announced an amendment to its License Agreement with Gurnet Point Capital that increases total potential milestone payments to $590 million for its ADHD treatment, AZSTARYS, which was FDA-approved on March 2, 2021. The amendment adds new royalty tiers on net sales, with rates ranging from the high single digits to mid-twenties percent in the U.S. The company aims to accelerate commercialization efforts, having eliminated debt and secured a cash reserve of over $77 million. A conference call is scheduled for today to discuss these developments.