As of the last check, Bausch Health Companies Inc. (NYSE: BHC) shares were up 9.25% at $7.32 following a tentative regulatory approval. At the close of the previous session, BHC’s stock was trading at $6.70.
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What has BHC received approval for?
Tentative approval of Norwich Pharmaceuticals’ rifaximin 200 mg product by the US Food and Drug Administration (FDA) has been announced today by Bausch Health (BHC) and its gastroenterology business Salix Pharmaceuticals.
As far as the Company is aware, this was a Paragraph III filing. Abbreviated New Drug Application (ANDA) applicants who do not intend to market their generic products until patents expire file a Paragraph III application. Consequently, the FDA will not grant full approval for XIFAXAN (rifaximin) 200 mg until after the expiration of the last patent listed in the Orange Book, on July 24, 2029.
Salix’s revenues are currently derived from less than 1 percent of the sales of XIFAXAN 200 mg, which is indicated for travelers’ diarrhea.
Further, BJHC clarified certain provisions in a separate news announcement yesterday regarding its previously announced exchange offers (the “Exchange Offers”) to exchange existing senior notes (the “Existing Senior Notes”) for new secured notes (the “New Secured Notes”), as well as its consent solicitation (the “Consent Solicitation”), according to the Exchange Offer Memorandum and Consent Solicitation Statement, dated August 30, 2022.
BHC has confirmed the following regarding the customary release and waiver provisions set forth in several clauses in response to certain concerns raised by holders of Existing Senior Notes:
- An Eligible Holder waives all other rights only in relation to the Existing Senior Notes actually exchanged in the Exchange Offers upon tendering its Existing Senior Notes in the Exchange Offers when such Eligible Holder tenders its Existing Senior Notes; releases Bausch Health and its affiliates from any and all claims a holder may have now, or in the future, arising from, or related to, the Existing Senior Notes that were actually exchanged in the Exchange Offers;
- The Eligible Holder retains all claims, causes of action, and rights under the retained Existing Senior Notes even if it does not exchange all of its Existing Senior Notes or if some of the exchanged Existing Senior Notes are returned to the Eligible Holder as a result of proration;
- As soon as the new Secured Notes are received by the tendering Eligible Holder, all of their claims, causes of action, and rights will become available.
BHC’s Other Move
Among other things, Bausch Health (BHC) has recently transferred approximately 38.6% of Bausch + Lomb’s issued and outstanding common shares to a wholly-owned subsidiary of the company.